CN109045302A - A kind of Polyethylene glycol vitamin E succinate powder and its preparation method and application - Google Patents
A kind of Polyethylene glycol vitamin E succinate powder and its preparation method and application Download PDFInfo
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- CN109045302A CN109045302A CN201810959157.5A CN201810959157A CN109045302A CN 109045302 A CN109045302 A CN 109045302A CN 201810959157 A CN201810959157 A CN 201810959157A CN 109045302 A CN109045302 A CN 109045302A
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- polyethylene glycol
- succinate
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
- A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline
- A61K31/353—3,4-Dihydrobenzopyrans, e.g. chroman, catechin
- A61K31/355—Tocopherols, e.g. vitamin E
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/02—Nutrients, e.g. vitamins, minerals
Abstract
The invention discloses a kind of Polyethylene glycol vitamin E succinate powder and its preparation method and application, belong to pharmaceutical raw material technical field.Preparation method includes: (1) melting: the wax-like Polyethylene glycol vitamin E succinate of raw material is warming up to 30-60 DEG C of thawing；(2) nonpolar solvent dissolve: by after thawing raw material and nonpolar solvent stirred and evenly mixed under the conditions of 30-60 DEG C；(3) vacuum is drained: being sucked by vacuum under the conditions of 10-30 DEG C of temperature and vacuum degree -0.06Mpa--0.098Mpa, is obtained Polyethylene glycol vitamin E succinate powder after draining solvent.The Polyethylene glycol vitamin E succinate powder, granule that the present invention obtains is in the same size, uniform, and mobility is fabulous.Its use is more more convenient than waxy product, in actual application have more extensive purposes, especially in terms of medicament solubilization, especially in terms of capsule is filled advantageously than wax-like products.
Description
Technical field
The invention belongs to pharmaceutical raw material technical fields, specifically disclose a kind of Polyethylene glycol vitamin E succinate powder
And its preparation method and application.
Background technique
Polyethylene glycol vitamin E succinate is water-soluble Tocopheryl derivatives, it has certain surfactant
Property can be used as the carrier of solubilizer, sorbefacient, emulsifier, plasticizer and fat-soluble medicine transmission system.In addition
It is alternatively arranged as the nutritional supplement of tocopherol, to treat some tocopherol mal-absorption diseases.
In the synthesis process of Polyethylene glycol vitamin E succinate, since its product is mostly waxy solid, determine
In subsequent application, product dissolution is mixed, and to be devoted a tremendous amount of time, be can be only achieved the requirement of all the components mixing.Its
Body waxy solid again cannot be by being simply mechanically pulverized to obtain powdery product.Due to itself being wax, application side
Just property is also limited by very large, more on the market about the dosage form master of Polyethylene glycol vitamin E succinate product formula
To be liquid and waxy solid, there is certain limitation, be prepared into water-soluble liquid form product, preparation process needs to expend big
The time of amount.And waxy solid is difficult to be made other dosage form, greatly limits practical application.
Based on the above circumstances, a kind of new method that can be prepared into powdery product is found, it can solve product and answering
Deficiency in, the time dissolved when products application can be greatly reduced improve the efficiency of products application.The powdery product of preparation
It can be with one of auxiliary materials such as starch, hydroxylmethyl cellulose beam, magnesium stearate or several mixed with main ingredient according to a certain percentage
It closes, may finally easily be prepared into a series of product such as capsule, pill and tablet, application prospect is more extensive.
Summary of the invention
The embodiment of the invention provides a kind of Polyethylene glycol vitamin E succinate powder, with wax-like polyethylene glycol dimension
Raw element E succinate is raw material preparation, and granular size accounts for 80% or more in 10-100 mesh.
Specifically, it using wax-like Polyethylene glycol vitamin E succinate as raw material, is dissolved through melting, nonpolar solvent and true
It is obtained after the dry grade of empty pump.
Preferably, it using wax-like Polyethylene glycol vitamin E succinate as raw material, is dissolved through melting, nonpolar solvent, is primary
It is obtained after vacuum drains, normal pressure growing the grain and secondary vacuum are drained etc.；Its granular size accounts for 90% or more in 60-100 mesh.
The present invention provides a kind of preparation methods of Polyethylene glycol vitamin E succinate powder, this method comprises:
(1) it melts: the wax-like Polyethylene glycol vitamin E succinate of raw material is warming up to 30-60 DEG C of thawing；
(2) nonpolar solvent dissolve: by after thawing raw material and nonpolar solvent stirred and evenly mixed under the conditions of 30-60 DEG C；
(3) vacuum is drained: being sucked by vacuum, is drained molten under the conditions of 10-30 DEG C of temperature and vacuum degree -0.06Mpa--0.098Mpa
Polyethylene glycol vitamin E succinate powder is obtained after agent.
Further, in step (1), melting time 0.5-3.0h；In step (2), mixing time 0.5-
3.0h。
Wherein, in step (2), nonpolar solvent is selected from petroleum ether, n-hexane, hexamethylene, ether, isopropyl ether, positive fourth
One or more of ether, pentane and heptane etc., preferably petroleum ether；Nonpolar solvent and polyethylene glycol VE succinic acid
The weight ratio of ester is 0.3-3.0:1, preferably 1:1.The nonpolar solvent that the present embodiment is added can only be miscible with product section, institute
Not need the amount of the increasing solvent as recrystallization.
Preferably, step (3) includes:
301 primary vacuum suctions: be sucked by vacuum under the conditions of 10-30 DEG C of temperature and vacuum degree -0.06Mpa--0.098Mpa to
Material stops when occurring muddy.
302 normal pressure growing the grains: the growing the grain 1-4h at 20-30 DEG C of temperature and condition of normal pressure；Wherein, growing the grain is to allow
Product particle degree is more uniform, not growing the grain also available product, it is possible that is obtained is waxy product, it is also possible to
What is obtained is a mixed system of waxy product and powder particle, it is uneven to cause granular size, and then make the application in product
Aspect effect is had a greatly reduced quality.Product particle size can be made to account for 90% or more in 60-100 mesh by growing the grain.
The suction of 303 secondary vacuums: vacuum is taken out under the conditions of 10-30 DEG C of temperature and vacuum degree -0.06Mpa--0.098Mpa
It inhales, obtains Polyethylene glycol vitamin E succinate powder after draining solvent.
Preferably, in 301: vacuum degree is -0.07Mpa--0.08Mpa；In 303: vacuum degree be-
0.095Mpa—-0.098Mpa；In 301 and 303, the temperature of vacuum suction is preferably 25 DEG C.
Preferably, the method include that
(1) it melts: the wax-like Polyethylene glycol vitamin E succinate of raw material is warming up to 30-60 DEG C of thawing, melting time 0.5-
3.0h；More preferably: temperature is 50 DEG C, time 2h.
(2) nonpolar solvent dissolve: by after thawing raw material and nonpolar solvent stirred and evenly mixed under the conditions of 30-60 DEG C,
Mixing time is 0.5-3.0h, and nonpolar solvent is selected from petroleum ether, n-hexane, hexamethylene, ether, isopropyl ether, n-butyl ether, pentane
One or more of with heptane, the weight of nonpolar solvent and Polyethylene glycol vitamin E succinate is 0.3-3.0:1；More
It is preferred that are as follows: temperature is 50 DEG C, time 1h, and nonpolar solvent is petroleum ether, petroleum ether and Polyethylene glycol vitamin E succinate
Weight ratio be 1:1.
(3) vacuum is drained: in 10-30 DEG C of temperature and vacuum degree -0.07Mpa -, -0.08Mpa(vacuum degree early period is small is convenient for
Material crystal form occurs, and slowly grows, and prevents vacuum too high, and just doing does not occur also in crystal, and avoids the occurrence of the big wax of granularity
Shape product) under the conditions of vacuum suction stop when occurring muddy to material；The growing the grain 1- at 20-30 DEG C of temperature and condition of normal pressure again
4h；It is finally high in 10-30 DEG C of temperature and vacuum degree -0.095Mpa--0.098Mpa(later period vacuum degree, it is because largely all
Form crystal, it is necessary to which high vacuum drains solvent) under the conditions of be sucked by vacuum, obtain polyethylene glycol vitamin E after draining solvent
Succinate powder.More preferably: vacuum suction temperature is 25 DEG C, and growing the grain temperature is 25 DEG C, rearing crystal time 3h.
In addition, the Polyethylene glycol vitamin E succinate powder obtained the present invention also provides aforementioned preparation process is answered
With the raw material as capsule pharmaceutical (is mainly used as solubilizer, also can be used as effective component, such as replenishing vitamins E), certainly may be used
For in tablet and pill.Powdery product can be mixed preferably with other raw materials, not only than wax-like in terms of capsule filling
Advantageously, and dissolubility is also better than wax-like products, greatly improves the bioavilability of product for product.
The Polyethylene glycol vitamin E succinate powdery product that the present invention obtains, powder particle is in the same size, uniformly,
Mobility is fabulous.Preparation method is economic and environment-friendly, no significant loss, easy to operate.The powder use obtained using this method than
Wax-like Polyethylene glycol vitamin E succinate is more convenient, has more extensive purposes in actual application, especially exists
In terms of medicament solubilization, powdery product has excellent mobility, not only more has in terms of capsule filling than wax-like products excellent
Gesture, and dissolubility is also better than wax-like products, greatly improves the bioavilability of product.
Specific embodiment
To make the object, technical solutions and advantages of the present invention clearer, embodiment of the present invention is made below further
Ground detailed description.
Embodiment 1
In the three-necked flask of 250ml, the wax-like Polyethylene glycol vitamin E succinate of 50g is added, is slowly warming up to 50 DEG C, and
In 50 DEG C of stirring 1h, 50g petroleum ether (boiling range is 60 DEG C -90 DEG C) is added, and in 50 DEG C of stirring 2h.
Stirring finishes, and temperature of charge is dropped to 35 DEG C, opens vacuum concentration at this time, and controlling vacuum degree is -0.07Mpa left
The right side, until temperature slowly drops to 25 DEG C and maintains.
When material becomes cloudy in flask, vacuum is removed, in atmospheric conditions, 25 DEG C, stirs growing the grain 3h.Growing the grain finishes,
Controlled at 20 DEG C -30 DEG C, vacuum degree is -0.095Mpa--0.098Mpa, drains until by nonpolar solvent, is finally
The powdered Polyethylene glycol vitamin E succinate product 49.7g of available white, yield 99.4%.Wherein, 60 mesh
The following are 1.7g, 60-80 mesh is 27.4g, and 80-100 mesh is 18.5g, and the above are 2.1g for 100 mesh；Product is concentrated mainly on 60-
Between 100 mesh, 92.4% is accounted for.
Embodiment 2
In the three-necked flask of 250ml, the wax-like Polyethylene glycol vitamin E succinate of 50g is added, is slowly warming up to 50 DEG C, and
In 40 DEG C of stirring 2h, 100g hexamethylene is added, and in 55 DEG C of stirring 1h.
Stirring finishes, and temperature of charge is dropped to 35 DEG C, opens vacuum at this time, and controlling vacuum degree is -0.08Mpa or so,
Until temperature slowly drops to 25 DEG C and maintains.
When material becomes cloudy in flask, vacuum is removed, in atmospheric conditions, 25 DEG C, stirs growing the grain 2h.Growing the grain finishes,
Controlled at 20 DEG C -30 DEG C, vacuum degree is -0.095Mpa--0.098Mpa, drains until by nonpolar solvent, is finally
The powdered Polyethylene glycol vitamin E succinate product 50.0g of available white, yield 100%.Wherein, 60 mesh with
It is down 1.3g, 60-80 mesh is 31.1g, and 80-100 mesh is 15.0g, and the above are 2.6g for 100 mesh；Product is concentrated mainly on 60-100
Between mesh, 92.2% is accounted for.
Embodiment 3
In the three-necked flask of 1000ml, the wax-like Polyethylene glycol vitamin E succinate of 350g is added, is slowly warming up to 50 DEG C,
And in 50 DEG C of stirring 1h, 350g petroleum ether (boiling range is 60 DEG C -90 DEG C) is added, and in 50 DEG C of stirring 1h.
Stirring finishes, and temperature of charge is dropped to 35 DEG C, opens vacuum at this time, and controlling vacuum degree is -0.08Mpa or so,
Until temperature slowly drops to 25 DEG C and maintains.
When material becomes cloudy in flask, vacuum is removed, in atmospheric conditions, 25 DEG C, stirs growing the grain 3h.Growing the grain finishes,
Controlled at 20 DEG C -30 DEG C, vacuum degree is -0.095Mpa--0.098Mpa, drains until by nonpolar solvent, is finally
The powdered Polyethylene glycol vitamin E succinate product 350.0g of available white, yield 100%.Wherein, 60 mesh
The following are 7.7g, 60-80 mesh is 131.8g, and 80-100 mesh is 199.2g, and the above are 11.3g for 100 mesh；Product is concentrated mainly on
Between 60-100 mesh, 94.6% is accounted for.
It can be seen that this method yield from the product of embodiment 1-3 and be essentially 100%, to product free of losses；It obtains simultaneously
Product, particle is uniform, and the product of 60-100 mesh accounts for 90% or more.
Comparative example 1
In the three-necked flask of 1000ml, the wax-like Polyethylene glycol vitamin E succinate of 350g is added, is slowly warming up to 50 DEG C,
And in 50 DEG C of stirring 1h, 350g petroleum ether (boiling range is 60 DEG C -90 DEG C) is added, and in 50 DEG C of stirring 1h.Stirring finishes, by material
Temperature drops to 20 DEG C -30 DEG C, and vacuum degree is -0.095Mpa--0.098Mpa, drains until by nonpolar solvent, last
To obtain Polyethylene glycol vitamin E succinate product 350.0g, yield 100%.Wherein, the following are 44.5g, 10-60 for 10 mesh
Mesh is 121.4g, and 60-80 mesh is 145.7g, and 80-100 mesh is 32.1g, and the above are 6.3g for 100 mesh；Product is concentrated mainly on 10-
Between 100 mesh, 84.5% is accounted for；60-100 mesh accounts for 50.8%, and product distribution range obviously becomes larger, and granularity is uneven.
Comparative example 2
100g waxy feedstock is taken, is put into disintegrating machine, 0.5min is smashed, it is found that it is wax-like product remains as, and form a mud
Shape.Illustrate to smash by simple physics and reaches requirement.
Comparative example 3
50g waxy feedstock is taken, stirring and dissolving in 50g petroleum ether is put into, is evaporated to obtain waxy product, powdery production can not be obtained
Product.
As can be seen that conventional crushing and routine is used to be evaporated, (recrystallization can only also be obtained from comparative example 2 and comparative example 3
To waxy product) powdery product can not be obtained.As can be seen that the product obtained by growing the grain process from comparative example 1
Granularity is more uniform.
Application examples 1
In 250ml flask, 95g water is put into, stirring is opened, is warming up to 60 DEG C -65 DEG C, takes the wax-like polyethylene glycol vitamin E of 5g
Succinate product is added in beaker, keeps the temperature timing, and final products are completely dissolved into water, forms the liquid of homogeneous phase, when cost
Between 53min.
In 250ml flask, 95g water is put into, stirring is opened, is warming up to 60 DEG C -65 DEG C, takes the powdered polyethylene glycol dimension of 5g
Raw element E succinate product is added in beaker, keeps the temperature timing, and final products are completely dissolved into water, forms the liquid of homogeneous phase, flower
Time-consuming 17min.
Powdery product is more shorter than the dissolution time that waxy product is spent in the two comparative experiments, and it is more preferable to illustrate that it has
Dissolubility.
Application examples 2
The wax-like Polyethylene glycol vitamin E succinate product of 100g is taken to mix with 100g magnesium stearate and (main ingredient is not added), due to producing
Product be it is wax-like, cannot mix, capsule product cannot finally be made.
The powdered Polyethylene glycol vitamin E succinate product of 100g is taken to mix with 100g magnesium stearate and (main ingredient is not added),
Since the two is powder, mix very well, and mobility is fabulous, can hold very much and capsule product is made.
The foregoing is merely presently preferred embodiments of the present invention, is not intended to limit the invention, it is all in spirit of the invention and
Within principle, any modification, equivalent replacement, improvement and so on be should all be included in the protection scope of the present invention.
Claims (10)
1. a kind of Polyethylene glycol vitamin E succinate powder, which is characterized in that with wax-like polyethylene glycol VE succinic acid
Ester is raw material preparation, and granular size accounts for 80% or more in 10-100 mesh.
2. Polyethylene glycol vitamin E succinate powder according to claim 1, which is characterized in that with wax-like poly- second two
Alcohol Vitamin E succinate is raw material, is obtained after melting, nonpolar solvent dissolution and vacuum are drained.
3. Polyethylene glycol vitamin E succinate powder according to claim 1, which is characterized in that with wax-like poly- second two
Alcohol Vitamin E succinate is raw material, is drained through melting, nonpolar solvent dissolution, a vacuum, normal pressure growing the grain and secondary vacuum
It is obtained after draining；Its granular size accounts for 90% or more in 60-100 mesh.
4. a kind of preparation method of Polyethylene glycol vitamin E succinate powder, which is characterized in that the described method includes:
(1) it melts: the wax-like Polyethylene glycol vitamin E succinate of raw material is warming up to 30-60 DEG C of thawing；
(2) nonpolar solvent dissolve: by after thawing raw material and nonpolar solvent stirred and evenly mixed under the conditions of 30-60 DEG C；
(3) vacuum is drained: being sucked by vacuum, is drained molten under the conditions of 10-30 DEG C of temperature and vacuum degree -0.06Mpa--0.098Mpa
Polyethylene glycol vitamin E succinate powder is obtained after agent.
5. the preparation method according to claim 4, which is characterized in that in step (1), melting time 0.5-3.0h；
In step (2), mixing time 0.5-3.0h.
6. the preparation method according to claim 4, which is characterized in that in step (2), the nonpolar solvent is selected from stone
One or more of oily ether, n-hexane, hexamethylene, ether, isopropyl ether, n-butyl ether, pentane and heptane, the nonpolar solvent
Weight ratio with Polyethylene glycol vitamin E succinate is 0.3-3.0:1.
7. the preparation method according to claim 4, which is characterized in that step (3) includes:
301 primary vacuum suctions: be sucked by vacuum under the conditions of 10-30 DEG C of temperature and vacuum degree -0.06Mpa--0.098Mpa to
Material stops when occurring muddy；
302 normal pressure growing the grains: the growing the grain 1-4h at 20-30 DEG C of temperature and condition of normal pressure；
The suction of 303 secondary vacuums: it is sucked by vacuum, takes out under the conditions of 10-30 DEG C of temperature and vacuum degree -0.06Mpa--0.098Mpa
Polyethylene glycol vitamin E succinate powder is obtained after dry solvent.
8. preparation method according to claim 7, which is characterized in that in 301: vacuum degree is -0.07Mpa--
0.08Mpa；In 303: vacuum degree is -0.095Mpa--0.098Mpa.
9. the preparation method according to claim 4, which is characterized in that the described method includes:
(1) it melts: the wax-like Polyethylene glycol vitamin E succinate of raw material is warming up to 30-60 DEG C of thawing, melting time 0.5-
3.0h；
(2) nonpolar solvent dissolve: by after thawing raw material and nonpolar solvent stirred and evenly mixed under the conditions of 30-60 DEG C, stir
Time is 0.5-3.0h, and the nonpolar solvent is selected from petroleum ether, n-hexane, hexamethylene, ether, isopropyl ether, n-butyl ether, pentane
One or more of with heptane, the weight ratio of the nonpolar solvent and Polyethylene glycol vitamin E succinate is 0.3-
3.0:1；
(3) vacuum is drained: vacuum suction to material goes out under the conditions of 10-30 DEG C of temperature and vacuum degree -0.07Mpa--0.08Mpa
Stop when existing muddy；The growing the grain 1-4h at 20-30 DEG C of temperature and condition of normal pressure again；Finally in 10-30 DEG C of temperature and vacuum degree-
It is sucked by vacuum under the conditions of 0.095Mpa--0.098Mpa, obtains Polyethylene glycol vitamin E succinate powder after draining solvent.
10. a kind of Polyethylene glycol vitamin E succinate powder obtained such as the described in any item preparation methods of claim 4-9
Application, which is characterized in that the raw material as capsule pharmaceutical.
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